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Director, Digitized Adverse Event Processing & Device Vigilance

Bristol Myers Squibb · Princeton, NJ · Today
$218k–$264k/yrFull-time

Position Summary

The Director, Digitized Case Processing & Device Vigilance is a senior leadership role accountable for the end-to-end strategy, design, implementation, and continuous improvement of digitized adverse event (AE) case processing workflows within BMS's global PV Operations & Systems function.

Duties/Responsibilities

  • Develop and execute the multi-year digital transformation roadmap for ICSR case processing, aligned with the BMS enterprise AI strategy and PV Operations roadmap.

  • Lead implementation of AI, NLP, OCR, RPA, and Large Language Model (LLM)-assisted tools to enable automated ingestion, triage, and processing of adverse event data from structured and unstructured sources (e.g., EHRs, free-text narratives, digital health applications, social media, medical literature, and partner data transfers).

  • Partner with BMS Digital & Technology (D&T) and external technology vendors to evaluate, validate, deploy and develop intelligent case processing platforms (e.g., ArisGlobal LifeSphere, IQVIA Vigilance Detect, Oracle Argus AI-augmented workflows) ensuring fit-for-purpose implementation.

  • Define and govern a human-in-the-loop (HITL) oversight framework ensuring all AI-assisted case decisions are subject to qualified medical/safety review, meeting applicable regulatory expectations and guidance on Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making.

  • Contribute to validation lifecycle of all AI/ML tools used within the ICSR processing workflow in accordance with 21 CFR Part 11, GxP computer systems validation (CSV), and emerging regulatory expectations.

  • Champion the adoption of ICH E2B(R3) digital submission standards across all BMS reporting pathways.

  • Accountable for BMS's global Medical Device Reporting (MDR) obligations under 21 CFR Part 803, ensuring timely (5-day and 30-day) eMDR submissions to the FDA for device-associated adverse events, malfunctions, and combination product safety issues.

  • Oversee compliance with EU MDR/IVDR device-related pharmacovigilance obligations and the integration of device malfunction data into ICSRs submitted to EudraVigilance under GVP Module VI using ICH E2B(R3) standards.

  • Develop and maintain combination product safety reporting procedures, defining clear decision rights and workflows to manage dual-reporting obligations (PV + MDR) across jurisdictions.

  • Partner with BMS Device Development, Regulatory Affairs, and Medical Affairs teams to ensure early identification and correct classification of device-related ICSRs at point of intake.

  • Monitor regulatory developments in device safety reporting and MRD standards across all BMS operating markets (US, EU, UK, Japan, India, Canada, etc.), and translate these into updated SOPs, training, and process changes.

Qualifications

  • Minimum Bachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Engineering, Computer Science, or a related Healthcare or Life Sciences field.

  • Advanced degree (Master's, PharmD, MD, or PhD) in a relevant discipline is preferred.

  • Additional qualifications in Digital Health, Data Science, AI/ML, or Health Informatics are highly desirable.

  • Minimum 10+ years of experience in Pharmacovigilance, Drug Safety, or a closely related field, with at least 3–5 years at Director or equivalent senior leadership level.

  • Minimum 7 years of hands-on ICSR case processing experience within a pharmaceutical, biotech, or CRO environment.

  • Demonstrated expertise in digital transformation of PV processes, including deployment of AI, NLP, OCR, RPA, or ML solutions within a regulated GxP environment.

  • Proven experience with device safety reporting obligations including MDR (21 CFR Part 803), EU MDR/IVDR, and combination product dual-reporting workflows.

  • Experience with global safety database systems (e.g., Oracle Argus, Veeva Vault Safety, ArisGlobal LifeSphere) and electronic submission platforms (FAERS, EudraVigilance, MHRA Yellow Card).

  • Working knowledge of ICH E2B(R3) electronic submission standards and associated data elements.

  • Prior experience managing geographically distributed, multicultural teams across multiple time zones (US, UK, and India exposure preferred).

  • Experience managing regulatory inspections (FDA, EMA, MHRA, or equivalent) related to case management or PV systems.

  • Prior engagement with AI governance frameworks or digital health regulatory policy is an advantage.

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